NCT01858987

Brief Summary

The optimal technique of parenchymal transection in liver surgery has remained a matter of controversial debate among hepatobiliary surgeons. The optimal technique should enable secure sealing of the vascular and biliary structures that results in low intraoperative blood loss as well as low postoperative complication rates. Although numerous devices have been introduced and are used widely, high-level evidence, randomized controlled trials, that evaluate efficacy and safety of these devices are scarce. In the present randomized controlled trial two techniques of hepatic resection using vascular staplers and the LigaSure vessel sealing device are compared. While the primary endpoint is intraoperative blood loss a set of general and surgical variables will be analyzed to evaluate efficacy and safety of both methods.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
138

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 2, 2011

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

May 16, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 21, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 17, 2014

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 14, 2014

Completed
Last Updated

October 9, 2017

Status Verified

October 1, 2017

Enrollment Period

2.7 years

First QC Date

May 16, 2013

Last Update Submit

October 6, 2017

Conditions

Liver Resection

Outcome Measures

Primary Outcomes (1)

  • Intraoperative Blood loss

    Intraoperative blood loss represents the primary efficacy endpoint of the CRUNSH II-Trial. To obtain a more precise estimate for the individual patient patient's individual transection area will be considered as a continuous covariate in the analysis of covariance (ANOVA). The transection area will be assessed using an imprint of the resected specimen on a paper sheet with a known density of 80 mg/m2. The marked paper area will be cut and weight to calculate the transection area. Intraoperative blood loss will be measured according to the blood collected in the suction containers. Spilling water and ascites will be subtracted. Furthermore, swabs will be squeezed and their content will also be sucked and added to the fluid collected in the suction containers. Central venous pressure will be lowered below 5 cmH2O for the transection period.

    Beginning to end of surgical procedure

Study Arms (2)

Stapler hepatectomy

ACTIVE COMPARATOR

Liver resection using vascular stapler for transection of the parenchyma

Procedure: Stapler hepatectomyOther: vascular staple

LigaSure Hepatectomy

EXPERIMENTAL

Liver resection using LigaSure for transection of the parenchyma

Procedure: LigaSure hepatectomyDevice: Ligasure

Interventions

Stapler hepatectomyPROCEDURE

Liver resection using vascular stapler for transection of the parenchyma

Stapler hepatectomy
LigaSure hepatectomyPROCEDURE

Liver resection using LigaSure for transection of the parenchyma

LigaSure Hepatectomy
LigasureDEVICE
LigaSure Hepatectomy
vascular stapleOTHER
Stapler hepatectomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients scheduled for elective hepatic resection
  • Parenchymal transection by vascular stapler and LigaSure feasible
  • Age equal or greater than 18 years
  • Informed consent

You may not qualify if:

  • Extrahepatic resection required based on preoperative imaging
  • Participation in concurrent surgical intervention trials
  • Expected lack of compliance
  • Impaired mental state or language problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UniversityHospital Dresden

Dresden, 01307, Germany

Location

Related Publications (1)

  • Fritzmann J, Kirchberg J, Sturm D, Ulrich AB, Knebel P, Mehrabi A, Buchler MW, Weitz J, Reissfelder C, Rahbari NN. Randomized clinical trial of stapler hepatectomy versus LigaSure transection in elective hepatic resection. Br J Surg. 2018 Aug;105(9):1119-1127. doi: 10.1002/bjs.10902.

    PMID: 30069876DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 16, 2013

First Posted

May 21, 2013

Study Start

November 2, 2011

Primary Completion

July 17, 2014

Study Completion

August 14, 2014

Last Updated

October 9, 2017

Record last verified: 2017-10

Locations

DE(1)